IPRATROPIUM + SALBUTAMOL (US, ALBUTEROL)
i pra troe' pee um + sal-byoo-tah-mole (al byoo' ter ole)
P / L : Caution during pregnancy and lactation
Indication(s) & Dosage
This combination is used in the management of bronchospasm in patients suffering from chronic obstructive pulmonary disease who require regular treatment with both ipratropium and salbutamol.
Inhalation Chronic obstructive pulmonary disease, Adult: Each inhalation contains ipratropium bromide 18mcg and salbutamol sulfate 103mcg: 2 inhalations 4 times daily. Max: 12 inhalations/24 hr. For nebulizing solution (each 3 ml contains ipratropium bromide 0.5 mg and salbutamol base 2.5 mg): Initially, 3 ml every 6 hr. Max: 3 ml every 4 hr.
May be taken with or without food.
Overdose may lead to hypokalaemia; monitor serum potassium. Other symptoms may include chest pain, hypertension and tachycardia. May treat using a cardioselective Beta (Î²)-blocker but agent should be used with care in patients with a history of bronchospasm.
This combination is contraindicated in patients with hypertrophic obstructive cardio- myopathy or tachyarrhythmia. this combination are also contraindicated in patients with a history of hypersensitivity to ipratropium bromide, salbutamol sulphate or to atropine or its derivatives.
Warning & Precautions
Immediate hypersensitivity reactions may occur after administration of this combination, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal oedema.
There have been rare reports of ocular complications (i.e. mydriasis, blurring of vision, narrow-angle glaucoma and eye pain) when the contents of metered aerosols containing ipratropium bromide have been sprayed inadvertently into the eye.
Patients must be instructed in the correct use of this combination and warned not to allow the solution or mist to enter the eyes. This is particularly important in patients who may be pre-disposed to glaucoma. Such patients should be warned specifically to protect their eyes. Eye pain or discomfort, blurred vision, visual halos or coloured images, in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
In the following conditions this combination should only be used after careful risk/benefit assessment: insufficiently controlled diabetes mellitus, recent myocardial infarction and/or severe organic heart or vascular disorders, hyperthyroidism, pheochromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.
Cardiovascular effects may be seen with sympathomimetic drugs including this combination.
There is some evidence from post-marketing data and published literature of rare occurences of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, tachyarrhythmia or severe heart failure) who are receiving salbutamol for respiratory disease, should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.
Potentially serious hypokalaemia may result from beta2-agonist therapy. Particular caution is advised in severe airway obstruction as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics. Additionally, hypoxia may aggravate the effects of hypokalaemia on cardiac rhythm (especially in patients receiving digoxin). It is recommended that serum potassium levels are monitored in such situations.
Patients with cystic fibrosis may be more prone to gastro-intestinal motility disturbances.
The patient should be instructed to consult a doctor immediately in the event of acute, rapidly worsening dyspnoea. In addition, the patient should be warned to seek medical advice should a reduced response become apparent.
As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway. this combination should be discontinued immediately, the patient should be assessed and alternative therapy instituted if necessary.
The use of this combination may lead to positive results with regards to salbutamol in tests for non clinical substance abuse, e.g. in the context of athletic performance enhancement (doping).
Bronchitis, respiratory tract infections. Chest pain, arrhythmia, oedema, hypertension, hypokalaemia, palpitation, tachycardia. Headache, dizziness, fatigue, insomnia, tremor, nervousness. GI symptoms e. g. nausea, vomiting, diarrhoea, dyspepsia and constipation. Potentially Fatal: Anaphylactic reactions such as angioedema of tongue, lips or face and laryngospasm.
May have additive anticholinergic effects when used with psychotropics; may decrease effect of propranolol. Increased CV effects (tachycardia, palpitations) when used with MAOIs, TCAs and amphetamines.
Inhalation: Store < 25Â°C.
Ipratropium bromide has anticholinergic (parasympatholytic) properties. In preclinical studies, it appears to inhibit vagally mediated reflexes by antagonising the action of acetylcholine, the transmitter agent released from the vagus nerve.
The bronchodilation following inhalation of ipratropium bromide is primarily local and site specific to the lung and not systemic in nature.
Salbutamol is a beta2-adrenergic agent which acts on airway smooth muscle resulting in relaxation. Salbutamol relaxes all smooth muscle from the trachea to the terminal bronchioles and protects against bronchoconstrictor challenges.
this combination provide the simultaneous delivery of ipratropium bromide and salbutamol sulphate allowing effects on both muscarinic and beta2-adrenergic receptors in the lung leading to increased bronchodilation over that provided by each agent singly.
Ipratropium bromide is an anticholinergic agent that inhibits vagally-mediated reflexes by antagonising the action of acetylcholine. It prevents the increases in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) which are brought about by interaction of acetylcholine with the muscarinic receptors on bronchial smooth muscle. Salbutamol is a direct-acting Beta (Î²)2-adrenergic agent. It acts on the airway smooth muscle resulting in bronchodilation. Distribution: Ipratropium: Minimally bound to plasma proteins. Excretion: Ipratropium: Elimination half-life: About 2 hr (after IV or inhalational administration). Plasma half-life of salbutamol: About 4-6 hr.
ATC code: R03A K04, adrenergics and other drugs for obstructive airway diseases. R03BB01 - ipratropium bromide; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, anticholinergics. R01AX03 - ipratropium bromide; Belongs to the class of other topical preparations used as nasal decongestants. R03AC02 - salbutamol; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases. R03CC02 - salbutamol; Belongs to the class of adrenergics for systemic use, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|IPRALIN HFA||Aristopharma Ltd.||Salbutamol BP 100mcg + Ipratropium Bromide BP 20mcg (200 MDI)||Inhaler (MDI)||200 MDI: 250.00 MRP|
|IPRASOL HFA||Beximco Pharmaceuticals Ltd||Salbutamol BP 100mcg + Ipratropium Bromide BP 20mcg (200 MDI)||Inhaler||200 MD: 230.00 MRP|
|IPRASOL SOLUTION||Beximco Pharmaceuticals Ltd||Ipratropium Bromide + Salbutamol Solution 20ml||Solution||20ml: 225.00 MRP|
|SALPIUM||The Acme Laboratories Ltd.||Salbutamol BP 100mcg + Ipratropium Bromide BP 20mcg (200 MDI)||Inhaler (MDI)||200 MDI: 230.86 MRP|
|SULPREX HFA||Square Pharmaceuticals Ltd.||Salbutamol + Ipratropium Bromide (100 mcg + 20 mcg)/puff||HFA Inhaler (CFC-Free)||200 puffs: 250.75 MRP|
|SULPREX HFA REFILL||Square Pharmaceuticals Ltd.||Salbutamol + Ipratropium Bromide (100 mcg + 20 mcg)/puff||HFA Refill (CFC-Free)||200 puffs: 230.69 MRP|
|SULPREX NEBU||Square Pharmaceuticals Ltd.||Salbutamol + Ipratropium Bromide (2.5mg + 500 mcg)/2.5 ml||Nebuliser Solution||2x5's: 150.50 MRP|
|Windel Plus||Incepta Pharmaceuticals Limited||Ipratropium Bromide 0.04% + Salbutamol 0.12% Nebuliser Solution||Nebuliser solution||10x1's:MRP 150 Tk|
Why is this medication prescribed?
The combination of Salbutamol (Albuterol) and ipratropium is used to prevent wheezing, difficulty breathing, chest tightness, and coughing in people with chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) such as chronic bronchitis (swelling of the air passages that lead to the lungs) and emphysema (damage to the air sacs in the lungs). Salbutamol (Albuterol) and ipratropium combination is used by people whose symptoms have not been controlled by a single inhaled medication. Salbutamol (Albuterol) and ipratropium are in a class of medications called bronchodilators. Salbutamol (Albuterol) and ipratropium combination works by relaxing and opening the air passages to the lungs to make breathing easier.
How should this medicine be used?
The combination of Salbutamol (Albuterol) and ipratropium may come as a solution to inhale by mouth using a nebulizer (machine that turns medication into a mist that can be inhaled) and as an aerosol to inhale by mouth using an inhaler. It is usually inhaled four times a day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Use Salbutamol (Albuterol) and ipratropium exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Your doctor may tell you to use additional doses of Salbutamol (Albuterol) and ipratropium combination if you experience symptoms such as wheezing, difficulty breathing, or chest tightness. Follow these directions carefully, and do not use extra doses of medication unless your doctor tells you that you should. Do not use more than 2 extra doses of the nebulizer solution per day. Do not use more than 12 puffs of the inhalation aerosol in 24 hours.
Consult your doctor if your symptoms worsen or if you feel that Salbutamol (Albuterol) and ipratropium inhalation no longer controls your symptoms. If you were told to use Salbutamol (Albuterol) and ipratropium as needed to treat your symptoms and you find that you need to use the medication more often than usual, consult your doctor.
If you are using the inhaler, your medication will come in canisters. Each canister of Salbutamol (Albuterol) and ipratropium aerosol is designed to provide 200 inhalations. After the labeled number of inhalations has been used, later inhalations may not contain the correct amount of medication. You should keep track of the number of inhalations you have used. You can divide the number of inhalations in your inhaler by the number of inhalations you use each day to find out how many days your inhaler will last. Throw away the canister after you have used the labeled number of inhalations even if it still contains some liquid and continues to release a spray when it is pressed. Do not float the canister in water to see if it still contains medication.
Be careful not to get Salbutamol (Albuterol) and ipratropium into your eyes. If you are using the inhaler, keep your eyes closed when you use the medication. If you get Salbutamol (Albuterol) and ipratropium in your eyes, you may develop narrow angle glaucoma (a serious eye condition that may cause loss of vision). If you already have narrow angle glaucoma, your condition may worsen. You may experience widened pupils (black circles in the center of the eyes), eye pain or redness, blurred vision, and vision changes such as seeing halos around lights. Consult your doctor if you get Salbutamol (Albuterol) and ipratropium into your eyes or if you develop these symptoms.
The inhaler that comes with Salbutamol (Albuterol) and ipratropium aerosol is designed for use only with a canister of Salbutamol (Albuterol) and ipratropium. Never use it to inhale any other medication, and do not use any other inhaler to inhale Salbutamol (Albuterol) and ipratropium.
Do not use your Salbutamol (Albuterol) and ipratropium inhaler when you are near a flame or source of heat. The inhaler may explode if it is exposed to very high temperatures.
Before you use Salbutamol (Albuterol) and ipratropium for the first time, read the written instructions that come with the inhaler or nebulizer. Ask your doctor, pharmacist, or respiratory therapist to show you how to use it. Practice using the inhaler or nebulizer while he or she watches.
To use the inhaler, follow these steps:
- Hold the inhaler with the clear end pointing upward. Place the metal canister into the clear end of the inhaler. Be sure that the canister is fully and firmly in place.
- Remove the protective dust cap from the end of the mouthpiece. If the dust cap was not placed on the mouthpiece, check the mouthpiece for dirt or other objects.
- If you are using the inhaler for the first time or if you have not used the inhaler in more than 24 hours, you will need to prime it. Shake it well for at least 10 seconds and then press down on the canister three times to release three sprays into the air, away from your face. Be careful not to get Salbutamol (Albuterol) and ipratropium in your eyes.
- Hold the inhaler between your thumb and your next two fingers with the mouthpiece on the bottom, facing you. Shake the inhaler well for at least 10 seconds.
- Immediately breathe out deeply through your mouth.
- Hold the canister with the mouthpiece on the bottom and facing you and the canister pointing upward. Place the open end of the mouthpiece into your mouth. Close your lips tightly around the mouthpiece. Close your eyes.
- Breathe in slowly and deeply through the mouthpiece. At the same time, press down once on the container to spray the medication into your mouth.
- Hold your breath for 10 seconds. Then remove the inhaler, and breathe out slowly.
- If you were told to use 2 puffs, wait about 2 minutes and then repeat steps 4 to 8.
- Replace the protective cap on the inhaler.
- To inhale the solution using a nebulizer, follow these steps:
- Remove one vial of medication from the foil pouch. Put the rest of the vials back into the pouch until you are ready to use them.
- Twist off the top of the vial and squeeze all of the liquid into the reservoir of the nebulizer.
- Connect the nebulizer reservoir to the mouthpiece or face mask.
- Connect the nebulizer reservoir to the compressor.
- Put the mouthpiece in your mouth or put on the face mask. Sit in a comfortable, upright position and turn on the compressor.
- Breathe in calmly, deeply, and evenly through your mouth for about 5 to 15 minutes until mist stops forming in the nebulizer chamber.
- Clean your inhaler or nebulizer regularly. Follow the manufacturer's directions carefully and ask your doctor if you have any questions about cleaning your inhaler or nebulizer.
Other uses for this medicine
This medication may be prescribed for other uses. Ask your doctor for more information.
What special precautions should I follow?
Before using Salbutamol (Albuterol) and ipratropium,
- tell your doctor if you are allergic to ipratropium, atropine, Salbutamol (Albuterol), levosalbutamol (levalbuterol), any other medications, soya lecithin, soybeans, or peanuts.
- tell your doctor what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: beta blockers such as atenolol, labetalol, metoprolol, nadolol, and propranolol; diuretics; epinephrine; medications for colds; other inhaled medications, especially other medications for asthma such as formoterol, metaproterenol, levosalbutamol (levalbuterol), and salmeterol; and terbutaline. Also tell your doctor if you are taking any of the following medications or if you have stopped taking them within the past 2 weeks: antidepressants such as amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, and trimipramine; or monoamine oxidase inhibitors such as isocarboxazid, phenelzine, tranylcypromine, and selegiline . Your doctor may have to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had glaucoma; difficulty urinating; a prostate condition; seizures; hyperthyroidism; high blood pressure; an irregular heartbeat; diabetes; or heart, liver, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using Salbutamol (Albuterol) and ipratropium, consult your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using Salbutamol (Albuterol) and ipratropium.
- you should know that Salbutamol (Albuterol) and ipratropium inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, consult your doctor right away. Do not use Salbutamol (Albuterol) and ipratropium inhalation again unless your doctor tells you that you should.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.
What side effects can this medication cause?
This medication may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- leg cramps
- difficulty urinating
- frequent urination
- pain when urinating
- voice changes
Some side effects can be serious. If you experience any of the following symptoms, consult your doctor immediately:
- fast heartbeat
- chest pain
- swelling of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- sore throat, fever, chills, and other signs of infection
Salbutamol (Albuterol) and ipratropium may cause other side effects. Consult your doctor if you have any unusual problems while you are using this medication.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: MedlinePlus, U.S. Natl. Library of Medicine
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
|| See FDA approved Brand Manufacturer's Prescribing Information |
||| Back to top ||